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Methods and compositions using substance p to promote wound healingRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, LymphokineMethods and compositions using substance p to promote wound healing description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070154448, Methods and compositions using substance p to promote wound healing. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS REFERENCE TO RELATED APPLICATIONS [0001] The present application claims benefit under 35 U.S.C. 119(e) of provisional applications U.S. Ser. No. 60/738,910, filed Nov. 22, 2005; U.S. Ser. No. 60/739,154, filed Nov. 22, 2005; and U.S. Ser. No. 60/740,489, filed Nov. 28, 2005. The contents of each of the above-referenced patent applications are hereby expressly incorporated herein by reference. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT [0002] Not applicable. BACKGROUND OF THE INVENTION [0003] 1. Field of the Invention [0004] The present invention relates generally to methods and compositions for the enhancement of cellular proliferation and for the treatment of wounds and other disorders. More specifically, the invention relates to the use of neuropeptides for wound treatment in general and corneal wound treatment and vascular wound treatment in particular and, more particularly, to the use of Substance P and analogs and conjugates thereof for such wound treatment, wherein the neuropeptide is incorporated into a delivery vehicle that contains a polymeric delivery carrier that increases the dwell time of the neuropeptide, thereby reducing the number of administrations required when compared to administration of the neuropeptide alone. [0005] 2. Detailed Description of the Background Art [0006] Traumatic injury and disease can cause damage to the skin, tissue, and body organs that requires cellular regeneration for healing. Accidental injuries such as cuts, abrasions, burns, and intentional surgical procedures result in wounds that can affect large areas of the skin or affected body organs and can require lengthy periods to heal. Long healing times are a particular problem with denervated regions of the extremities and with wounds on sensitive areas, such as corneal wounds and wounds on the bottom of the feet, buttocks and other weight bearing surfaces, which are difficult to treat over prolonged periods. For these reasons, it would be desirable to provide methods and pharmacological agents which can be used to promote rapid healing of wounds and other injuries to the skin, tissue, and body organs. [0007] A variety of cellular growth promoting hormones have been identified that are capable of enhancing cellular proliferation, and these hormones have been used in the treatment of wounds. Exemplary growth promoting hormones include, but are not limited to, cytokines, lymphokines, interleukins, chemokines, epidermal growth factor, platelet-derived growth factor, insulin, insulin-like growth factor, transforming growth factor-.beta., nerve cell growth factor, fibroblast growth factor, platelet-derived growth factor, granulocyte-colony stimulating factor, granulocyte-macrophage colony stimulating factor, neurotropins, erythropoietin, thrombopoietin, myostatin, growth differentiating factor-9, hepatocyte growth factor, and the like. While use of these hormones continues to hold promise, no one growth promoting agent is known to be optimal for all situations. Thus, it would be desirable to identify additional substances and compositions which have therapeutic value as growth promoting agents, and it would be further desirable to identify substances and compositions which are capable of enhancing or modulating the effect of these and other growth promoting substances alone or in combination with other substances. [0008] In addition to cellular proliferation, wound healing requires the elaboration of extracellular matrices and development of cellular attachment mechanisms in order to achieve normal tissue morphology. For example, the formation of fibronectin is an important function in normal wound healing. Without sufficient expression of fibronectin and other cellular matrix substances, regenerated tissue can have an abnormal morphology. Thus, it would be desirable to identify substances and compositions which could promote such additional wound healing responses. [0009] U.S. Pat. No. 5,616,562, issued to Murphy et al. on Apr. 1, 1997 and expressly incorporated herein by reference in its entirety, discloses methods and compositions using Substance P to promote wound healing. The '562 patent discloses methods of healing a corneal or epithelial wound in a Substance P deficient patient, and such methods require multiple administrations of Substance P at frequent time intervals to treat the corneal or epithelial wound. Therefore, methods of treating corneal or epithelial wounds with a composition including Substance P that could increase the dwell time of the Substance P and thereby decrease the required number of administrations of the composition, are desired. In addition, methods of treating wounds other than corneal or epithelial wounds with Substance P are also desired. [0010] For the above reasons, it is an object of the present invention to provide pharmacological agents and formulations useful for the topical treatment of wounds and other disorders. Desirably, the compositions will be capable of providing a potent mitogenic activity which enhances the proliferation of epithelial cells, fibroblasts, and the like. The compositions, in certain embodiments, should also be capable of stimulating the expression of extracellular matrices and development of cellular attachment mechanisms which contribute to normal morphology in the healed tissue. In one embodiment, the compositions should be capable of enhancing or modulating the growth promoting activity of other growth promotants. The compositions should be suitable for topical application to the skin and body organs, including the eye and skin, and should also be suitable for administration to treat vascular wounds. In addition, the compositions of the present invention should further be suitable for incorporation into a wide variety of delivery vehicles such as but not limited to, salves, lotions, creams which may or may not include such additional components as Aloe Vera, Oat Beta Glucan, Hyaluronic Acid and other large polymeric delivery carriers. SUMMARY OF THE INVENTION [0011] According to the present invention, neuropeptides, including but not limited to, tachykinins, calcitonin gene-related peptide, analogs thereof, and conjugates thereof are applied topically to wounds in mammalian tissue in order to promote healing. Such neuropeptides have been found to possess cellular growth promoting activity when administered alone to a wound in tissue and have been further found to provide enhanced growth promoting activity when combined with other cellular growth promotants, such as epidermal growth factor, transforming growth factor-.beta., insulin, insulin-like growth factor, nerve growth factor, and platelet derived growth factor. In addition, the neuropeptides have been found to promote the elaboration of cellular matrices and the development of cellular attachment mechanisms which enhance the regeneration of tissue having a substantially normal morphology. [0012] Compositions according to the present invention include the neuropeptide and/or an analog and/or a conjugate thereof present in a vehicle suitable for topical application and may optionally include a growth promoting hormone, such as one of the growth promotants listed herein. According to one method of the present invention, the compositions are applied in an amount and at a concentration sufficient to promote healing of the wound being treated. Wounds which may be treated include cutaneous wounds, corneal wounds, wounds to the epithelial-lined hollow body organs, vascular wounds, and the like. Such wounds may result from trauma, surgical procedures, and disease. [0013] The compositions of the present invention also include Substance P present in a vehicle suitable for topical application in mammalian tissues, in particular, for ocular or cutaneous application. The preferred Substance P compositions of the method of the present invention may be applied to a patient in an amount and at a concentration sufficient to promote healing of the wound being treated. Any wound may be treated advantageously with Substance P; examples of wounds that may be treated by Substance P include, but are not limited to, epithelial and corneal wounds, cutaneous non-healing wounds, or wounds that result from any one or more of the following conditions of metaherpetic keratitis, viral infection, galactosemic or diabetic keratopathy, thermal or chemical burns, nerve destruction, corneal epithelial defect and failure to heal post penetrating keratoplasty. [0014] The present invention includes methods for promoting healing of a wound in a patient, wherein the methods include applying a composition to the wound in an amount sufficient to promote healing of the wound. The compositions utilized in such method comprise substance P or at least one analog thereof and a polymeric delivery vehicle, wherein the polymeric delivery vehicle present in the composition increases the dwell time of the substance P or at least one analog thereof such that the number of administrations of the composition required for promoting healing of the wound in the patient is reduced when compared to the number of administrations required for substance P or at least one analog thereof alone. The polymeric delivery vehicle may be selected from the group consisting of hyaluronic acid, chondroitin, hydroxymethyl cellulose, paraffin, cetyl alcohol, polyethylene glycol, gelatin, sodium alginate, methyl cellulose, carboxymethyl cellulose, plastibase hydrophilic gelatin, dextrin, stearyl alcohol, polyethylene glycol, polyvinyl alcohol, methoxyethylene-maleic anhydride, nanoparticles, liposomes, combinations thereof, modifications thereof and derivatives thereof. [0015] The compositions utilized in such methods may further include at least one growth factor, which may be selected from the group consisting of cytokines, lymphokines, interleukins, chemokines, epidermal growth factor, platelet-derived growth factor, insulin, insulin-like growth factor, transforming growth factor-.beta., nerve cell growth factor, fibroblast growth factor, platelet-derived growth factor, granulocyte-colony stimulating factor, granulocyte-macrophage colony stimulating factor, neurotropins, erythropoietin, thrombopoietin, myostatin, growth differentiating factor-9, hepatocyte growth factor, and combinations thereof. [0016] The wound to which the composition is applied may be a vascular wound, such as but not limited to, burns, diabetic ulcers, decubitus ulcers, and venous stasis ulcers. [0017] The present invention further includes compositions that comprise Substance P or at least one analog thereof and a polymeric delivery vehicle, wherein the substance P or at least one analog thereof and the polymeric delivery vehicle are present in a lotion, cream or ointment suitable for cutaneous application. The polymeric delivery vehicle may be selected from the group consisting of hyaluronic acid, chondroitin, hydroxymethyl cellulose, paraffin, cetyl alcohol, polyethylene glycol, gelatin, sodium alginate, methyl cellulose, carboxymethyl cellulose, plastibase hydrophilic gelatin, dextrin, stearyl alcohol, polyethylene glycol, polyvinyl alcohol, methoxyethylene-maleic anhydride, nanoparticles, liposomes, combinations thereof, modifications thereof and derivatives thereof. The composition may further include at least one growth factor that may be selected from the group consisting of cytokines, lymphokines, interleukins, chemokines, epidermal growth factor, platelet-derived growth factor, insulin, insulin-like growth factor, transforming growth factor-.beta., nerve cell growth factor, fibroblast growth factor, platelet-derived growth factor, granulocyte-colony stimulating factor, granulocyte-macrophage colony stimulating factor, neurotropins, erythropoietin, thrombopoietin, myostatin, growth differentiating factor-9, hepatocyte growth factor, and combinations thereof. [0018] The present invention is also directed to wound dressings that include a natural or synthetic bandage having a composition embedded or impregnated therein or coated thereon, wherein the composition comprises Substance P or at least one analog thereof and a polymeric delivery vehicle. The polymeric delivery vehicle of the composition may be selected from the group consisting of hyaluronic acid, chondroitin, hydroxymethyl cellulose, paraffin, cetyl alcohol, polyethylene glycol, gelatin, sodium alginate, methyl cellulose, carboxymethyl cellulose, plastibase hydrophilic gelatin, dextrin, stearyl alcohol, polyethylene glycol, polyvinyl alcohol, methoxyethylene-maleic anhydride, nanoparticles, liposomes, combinations thereof, modifications thereof and derivatives thereof. The composition of the wound dressing may further include at least one growth factor that may be selected from the group consisting of cytokines, lymphokines, interleukins, chemokines, epidermal growth factor, platelet-derived growth factor, insulin, insulin-like growth factor, transforming growth factor-.beta., nerve cell growth factor, fibroblast growth factor, platelet-derived growth factor, granulocyte-colony stimulating factor, granulocyte-macrophage colony stimulating factor, neurotropins, erythropoietin, thrombopoietin, myostatin, growth differentiating factor-9, hepatocyte growth factor, and combinations thereof. [0019] The present invention further includes methods for promoting healing of a vascular wound in a patient. Such methods include applying a composition to the vascular wound in an amount sufficient to promote healing of the vascular wound, wherein the composition comprises substance P or at least one analog thereof. The composition may further include at least one growth factor that may be selected from the group consisting of cytokines, lymphokines, interleukins, chemokines, epidermal growth factor, platelet-derived growth factor, insulin, insulin-like growth factor, transforming growth factor-.beta., nerve cell growth factor, fibroblast growth factor, platelet-derived growth factor, granulocyte-colony stimulating factor, granulocyte-macrophage colony stimulating factor, neurotropins, erythropoietin, thrombopoietin, myostatin, growth differentiating factor-9, hepatocyte growth factor, and combinations thereof. [0020] Other objects, features and advantages of the present invention will become apparent from the following detailed description when read in conjunction with the accompanying figures and appended claims. Continue reading about Methods and compositions using substance p to promote wound healing... 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